Production of clinical-grade SARS-CoV-2 antigen specific cytotoxic T lymphocytes

Not Applicable

Recruiting

Conditions: Certain infectious and parasitic diseases

Registration Number: KCT0005864

Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

For COVID-19 treated individuals:
1. Those who consent to the study
2. Aged 20 - to 65 years old
3. Individual who has been diagnosed with COVID-19 and released from quarantine, that is, the person who meets all the criteria for public release by the CDC:
A. (clinical standard): no fever and no clinical symptoms
B. (diagnostic criteria) PCR test results are negative twice every 24 hours

For health donors:
1. Those who consent
2. Aged 20 to 65 years old
3. Those who do not have any fever or respiratory symptoms
4. Negative for Anti-SARS-CoV-2 Ab IgG antibodies

Exclusion Criteria

1. Those who do not consent
2. Those under 20 or over 65 years of age
3. Positive for Anti-SARS-CoV-2 IgG antibodies
4. Positive for HIV, syphilis or hepatitis B and C carriers.
5. Those with any active infections requiring systemic medical treatment
6. Those who have been diagnosed with any other serious diseases

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of CD3 T cell marker in culture-expanded virus antigen specific T cells by flow cytometry;Expression of CD14 monocyte and CD19 B cell marker in culture-expanded virus antigen specific T cells by flow cytometry;Determining antigen specificity by detecting IFN-gamma secretion of culture expanded virus antigen-specific T cells against coronavirus-19 peptides through ELISPOT assay

Secondary Outcome Measures

Name	Time	Method
Fold expansion following culture of SARS-CoV-2 virus antigen peptide mixture treated peripheral nucleated cells;Characterization of cultured cells (Phenotypical analysis of cultured cells through flow cytometry)